Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)

• Registration Number: NCT00675597
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.

Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-08
• Study First Posted: 2008-05-09
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2015-10
• Results First Submitted: 2015-10-20
• Results First Submitted QC: 2015-10-20
• Last Update Submitted: 2015-10-20
• Results First Posted: 2015-11-20
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients must be at least 2 weeks status post complete (R0) surgical resection of pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed independently at MSKCC.
• Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below).
• Allergy to cisplatin
• Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (CTCAE grade > or equal to 2)
• Baseline renal insufficiency (defined as a creatinine clearance of < than or equal to 60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
• Performance status 70% on the Karnofsky scale.
• Congestive heart failure with New York Heart Association functional classification > or equal to II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
• Patient refuses to take cisplatin.
• Age > than or equal 18
• Performance Status Karnofsky > than or equal to 70%
• Peripheral neuropathy must be < than grade 1
• Hematologic (minimal values)
• Absolute neutrophil count > than or equal to 1,500/mm3
• Hemoglobin > than or equal to 8.0 g/dl
• Platelet count > than or equal to 100,000/mm3 Hepatic
• Total Bilirubin < than or equal to 1.5 x ULN AST or ALT and Alkaline Phosphatase must be within the range allowing for eligibility
• Women of childbearing potential must have a negative pregnancy test.
• Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
• Patients being considered for treatment with bevacizumab must have a urine protein: creatinine (UPC) ratio < 1.0 at screening and an MRI of brain or CT brain with IV contrast showing no evidence of brain metastases within 3 months of study entry

Read More

Exclusion Criteria

• > 16 weeks post-op
• Prior post-operative radiation
• > 1 cycle of prior adjuvant chemotherapy
• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
• Women who are pregnant, or breast-feeding.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)	Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer

Primary Outcome Measures

Name	Time	Method
To Measure the Number of Cycles	2 years	Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.

Trial Locations

Locations (5)

Memorial Sloan-Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan-Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan-Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center; 🇺🇸 Sleepy Hollow, New York, United States